A Notice to Stakeholders was released regarding the EU-Turkey Customs Union Agreement for medical devices. The gist of the document is that the same recognition under the Medical Device Regulation old Directives, also applies under the (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Specifically, it confirms the following under the MDR/IVDR:
- Confirms that European Economic Area manufacturers do not need an authorized representative to place devices onto the Turkish market, and vice versa.
- EU manufacturers must appoint an European Authorized Representative (EU AR). That EU AR can be located in the EEA or Turkey.